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A practical randomized controlled trial of hypoxia inducible factor prolyl hydroxylase inhibitor in the treatment of cardio-renal-anemia syndrome

A practical randomized controlled trial of hypoxia inducible factor prolyl hydroxylase inhibitor in the treatment of cardio-renal-anemia syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050031
Enrollment
Unknown
Registered
2021-08-16
Start date
2021-08-10
Completion date
Unknown
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cardio-renal-anemia syndrome

Interventions

Roxadustat group:Roxadustat capsule

Sponsors

Beijing Hepingli Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Meet the diagnostic criteria of renal anemia and chronic heart failure; 3. NYHA cardiac function grade II - IV, lasting for more than 4 weeks; 4. Non dialysis patients with CKD stage 3a-5; 5. Hb 70 to 100 g / L; 6. Sign informed consent;

Exclusion criteria

Exclusion criteria: 1. Serious cardiovascular and cerebrovascular events within the past 3 months, including myocardial infarction, acute coronary syndrome, stroke, epilepsy or thromboembolism (such as deep vein thrombosis or pulmonary embolism); 2. Chronic inflammatory diseases that affect erythropoiesis, such as systemic lupus erythematosus, rheumatoid arthritis, celiac disease); 3. Patients with anemia caused by causes other than CKD, such as myelodysplastic syndrome, multiple myeloma, hereditary blood diseases, etc.; 4. Women who are pregnant or breastfeeding; 5. Severe hepatic insufficiency; 6. Other serious systemic diseases; 7. Those who are known to be allergic to the test drug and/or its components; 8. Those with mental illness who cannot cooperate.

Design outcomes

Primary

MeasureTime frame
6-minute walk test;echocardiography;inflammatory markers;

Secondary

MeasureTime frame
all cause death, cardiovascular death;cardiovascular events;hospitalization for worsening heart failure;quality of life assessment;progression of cardiac function;anemia related indicators;Safety parameters (ECG, liver function, renal function, blood routine, urine routine);

Countries

China

Contacts

Public ContactWen Yumin

Beijing Hepingli Hospital

colline0725@163.com+86 10 58043183

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026